Methods and apparatus for transmitting vibrations

ABSTRACT

Methods and apparatus for transmitting vibrations via an electronic and/or transducer assembly through a dental implant are disclosed herein. The assembly may be attached, adhered, or otherwise embedded into or upon the implant to form a hearing assembly. The electronic and transducer assembly may receive incoming sounds either directly or through a receiver to process and amplify the signals and transmit the processed sounds via a vibrating transducer element coupled to a tooth or other bone structure, such as the maxillary, mandibular, or palatine bone structure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/866,345 filed Oct. 2, 2007 which is incorporated by reference in itsentirety herewith.

FIELD OF THE INVENTION

The present invention relates to methods and apparatus for transmittingvibrations through teeth or bone structures in and/or around a mouth.

BACKGROUND OF THE INVENTION

Hearing loss affects over 31 million people in the United States (about13% of the population). As a chronic condition, the incidence of hearingimpairment rivals that of heart disease and, like heart disease, theincidence of hearing impairment increases sharply with age.

While the vast majority of those with hearing loss can be helped by awell-fitted, high quality hearing device, only 22% of the total hearingimpaired population own hearing devices. Current products anddistribution methods are not able to satisfy or reach over 20 millionpersons with hearing impairment in the U.S. alone.

Hearing loss adversely affects a person's quality of life andpsychological well-being. Individuals with hearing impairment oftenwithdraw from social interactions to avoid frustrations resulting frominability to understand conversations. Recent studies have shown thathearing impairment causes increased stress levels, reducedself-confidence, reduced sociability and reduced effectiveness in theworkplace.

The human ear generally comprises three regions: the outer ear, themiddle ear, and the inner ear. The outer ear generally comprises theexternal auricle and the ear canal, which is a tubular pathway throughwhich sound reaches the middle ear. The outer ear is separated from themiddle ear by the tympanic membrane (eardrum). The middle ear generallycomprises three small bones, known as the ossicles, which form amechanical conductor from the tympanic membrane to the inner ear.Finally, the inner ear includes the cochlea, which is a fluid-filledstructure that contains a large number of delicate sensory hair cellsthat are connected to the auditory nerve.

Hearing loss can also be classified in terms of being conductive,sensorineural, or a combination of both. Conductive hearing impairmenttypically results from diseases or disorders that limit the transmissionof sound through the middle ear. Most conductive impairments can betreated medically or surgically. Purely conductive hearing lossrepresents a relatively small portion of the total hearing impairedpopulation (estimated at less than 5% of the total hearing impairedpopulation).

Sensorineural hearing losses occur mostly in the inner ear and accountfor the vast majority of hearing impairment (estimated at 90-95% of thetotal hearing impaired population). Sensorineural hearing impairment(sometimes called “nerve loss”) is largely caused by damage to thesensory hair cells inside the cochlea. Sensorineural hearing impairmentoccurs naturally as a result of aging or prolonged exposure to loudmusic and noise. This type of hearing loss cannot be reversed nor can itbe medically or surgically treated; however, the use of properly fittedhearing devices can improve the individual's quality of life.

Conventional hearing devices are the most common devices used to treatmild to severe sensorineural hearing impairment. These are acousticdevices that amplify sound to the tympanic membrane. These devices areindividually customizable to the patient's physical and acousticalcharacteristics over four to six separate visits to an audiologist orhearing instrument specialist. Such devices generally comprise amicrophone, amplifier, battery, and speaker. Recently, hearing devicemanufacturers have increased the sophistication of sound processing,often using digital technology, to provide features such asprogrammability and multi-band compression. Although these devices havebeen miniaturized and are less obtrusive, they are still visible andhave major acoustic limitation.

Industry research has shown that the primary obstacles for notpurchasing a hearing device generally include: a) the stigma associatedwith wearing a hearing device; b) dissenting attitudes on the part ofthe medical profession, particularly ENT physicians; c) product valueissues related to perceived performance problems; d) general lack ofinformation and education at the consumer and physician level; and e)negative word-of-mouth from dissatisfied users.

Other devices such as cochlear implants have been developed for peoplewho have severe to profound hearing loss and are essentially deaf(approximately 2% of the total hearing impaired population). Theelectrode of a cochlear implant is inserted into the inner ear in aninvasive and non-reversible surgery. The electrode electricallystimulates the auditory nerve through an electrode array that providesaudible cues to the user, which are not usually interpreted by the brainas normal sound. Users generally require intensive and extendedcounselling and training following surgery to achieve the expectedbenefit.

Other devices such as electronic middle ear implants generally aresurgically placed within the middle ear of the hearing impaired. Theyare surgically implanted devices with an externally worn component.

The manufacture, fitting and dispensing of hearing devices remain anarcane and inefficient process. Most hearing devices are custommanufactured, fabricated by the manufacturer to fit the ear of eachprospective purchaser. An impression of the ear canal is taken by thedispenser (either an audiologist or licensed hearing instrumentspecialist) and mailed to the manufacturer for interpretation andfabrication of the custom molded rigid plastic casing. Hand-wiredelectronics and transducers (microphone and speaker) are then placedinside the casing, and the final product is shipped back to thedispensing professional after some period of time, typically one to twoweeks.

The time cycle for dispensing a hearing device, from the firstdiagnostic session to the final fine-tuning session, typically spans aperiod over several weeks, such as six to eight weeks, and involvesmultiple with the dispenser.

Accordingly, there exists a need for methods and devices which areefficacious and safe in facilitating the treatment of hearing loss inpatients.

In another trend, more and more dentists and oral surgeons have turnedto dental implants as an acceptable and appropriate means to restore atooth that has been lost because of disease or trauma. Such dentalimplants offer an attractive alternative to other options because with adental implant the patient realizes a restoration that closelyapproximates a natural tooth without having to alter the structure orappearance of adjacent natural teeth which occurs, for example, when apatient chooses a bridge option. U.S. Pat. No. 5,984,681 discloses animplant for insertion into the alveolar bone of a patient and whereinthe implant is provided with a generally vertically projecting anchoringpin that extends from the implant into the alveolar bone of the patientand effectively interconnects the implant with the alveolar bone.

SUMMARY OF THE INVENTION

Methods and apparatus for transmitting vibrations via an electronicand/or transducer assembly through an implant are disclosed herein. Theassembly may be rigidly attached, adhered, reversibly connected, orotherwise embedded into or upon the implant to form a hearing assembly.The electronic and transducer assembly may receive incoming soundseither directly or through a receiver to process and amplify the signalsand transmit the processed sounds via a vibrating transducer elementcoupled to a tooth or other bone structure, such as the maxillary,mandibular, or palatine bone structure.

In one aspect, the apparatus for transmitting vibrations via at leastbone or tissue to facilitate hearing in a patient includes an implanthaving an implant head and a threaded portion adapted to be positionedbelow a gum line: and a housing coupled to the implant head and invibratory communication with the implant head, the housing having anactuatable transducer disposed within or upon the housing.

In another aspect, a method of transmitting vibrations via at least onedental implant includes placing the dental implant on a patient; andpositioning an actuatable transducer such that the implant andtransducer remain in vibratory communication.

One example of a method for transmitting these vibrations via at leastone tooth may generally comprising positioning a housing of theremovable oral appliance onto at least one tooth, whereby the housinghas a shape which is conformable to at least a portion of the tooth, andmaintaining contact between a surface of the tooth with an actuatabletransducer such that the surface and transducer remain in vibratorycommunication.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates the dentition of a patient's teeth and one embodimentof a hearing aid implanted device.

FIG. 2 illustrates a detail perspective view of the oral implantappliance positioned upon the patient's teeth utilizable in combinationwith a transmitting assembly external to the mouth and wearable by thepatient in another variation of the device.

FIG. 3 shows an illustrative configuration of the individual componentsin a variation of the oral appliance device having an externaltransmitting assembly with a receiving and transducer assembly withinthe mouth.

FIG. 4 shows an illustrative configuration of another variation of thedevice in which the entire assembly is contained by the oral appliancewithin the user's mouth.

FIGS. 5A and 5B illustrate perspective and side views, respectively, ofan oral appliance which may be coupled to a screw or post implanteddirectly into the underlying bone, such as the maxillary or mandibularbone.

FIGS. 5C and 5D illustrate two additional dental implant embodiments.

FIG. 6 illustrates another variation in which the oral appliance may becoupled to a screw or post implanted directly into the palate of apatient.

FIGS. 7A and 7B illustrate perspective and side views, respectively, ofan oral appliance which may have its transducer assembly or a couplingmember attached to the gingival surface to conduct vibrations throughthe gingival tissue and underlying bone.

FIG. 8 illustrates an example of how multiple oral appliance hearing aidassemblies or transducers may be placed on multiple teeth throughout thepatient's mouth.

FIG. 9 illustrates a perspective view of an oral appliance (similar to avariation shown above) which may have a microphone unit positionedadjacent to or upon the gingival surface to physically separate themicrophone from the transducer to attenuate or eliminate feedback.

FIG. 10 illustrates another variation of a removable oral appliancesupported by an arch and having a microphone unit integrated within thearch.

FIG. 11 shows yet another variation illustrating at least one microphoneand optionally additional microphone units positioned around the user'smouth and in wireless communication with the electronics and/ortransducer assembly.

FIGS. 12A, 12B and 12C show various views of one embodiment of anelectro-magnetic based attachment to implants for transmission ofvibrations to teeth.

FIGS. 13A, 13B, 13C and 13D show various embodiments of mechanical basedattachments to implants for transmission of vibrations to teeth.

FIGS. 14A and 14B show various views of one embodiment of a chemicalbased attachment to implants for transmission of vibrations to teeth.

DETAILED DESCRIPTION OF THE INVENTION

An electronic and transducer device may be attached, adhered, orotherwise embedded into or upon a dental implant appliance to form ahearing aid assembly. Such an oral appliance may be a custom-made dentalimplant device. The electronic and transducer assembly may receiveincoming sounds either directly or through a receiver to process andamplify the signals and transmit the processed sounds via a vibratingtransducer element coupled to a tooth or other bone structure, such asthe maxillary, mandibular, or palatine bone structure.

As shown in FIG. 1, a patient's mouth and dentition 10 is illustratedshowing one possible location for removably attaching hearing aidassembly 14 upon or against at least one implant 12 connected to bone ortissues or one tooth, such as a dental screw 12. The patient's tongue TGand palate PL are also illustrated for reference. An electronics and/ortransducer assembly 16 may be attached, adhered, or otherwise embeddedinto or upon the assembly 14 using magnetic, mechanical, or chemicalattachment as described below in further detail.

FIG. 2 shows a perspective view of the patient's lower dentitionillustrating the hearing aid assembly 14 comprising a removable oralappliance 18 and the electronics and/or transducer assembly 16positioned along a surface of the assembly 14. In this variation, oralappliance 18 may be positioned on or above screw 12 implanted into thepatient's bone or tissue. Moreover, electronics and/or transducerassembly 16 can be fitted inside the oral appliance 18. The figures areillustrative of variations and are not intended to be limiting;accordingly, other configurations and shapes for oral appliance 1.8 areintended to be included herein.

Generally, the volume of electronics and/or transducer assembly 16 maybe minimized so as to be unobtrusive and as comfortable to the user whenplaced in the mouth. Although the size may be varied, a volume ofassembly 16 may be less than 800 cubic millimeters. This volume is, ofcourse, illustrative and not limiting as size and volume of assembly 16and may be varied accordingly between different users.

In one variation, with assembly 14 positioned upon screw 12, as shown inFIG. 2, an extra-buccal transmitter assembly 22 located outside thepatient's mouth may be utilized to receive auditory signals forprocessing and transmission via a wireless signal 24 to the electronicsand/or transducer assembly 16 positioned within the patient's mouth,which may then process and transmit the processed auditory signals viavibratory conductance to the underlying tooth and consequently to thepatient's inner ear.

The transmitter assembly 22, as described in further detail below, maycontain a microphone assembly as well as a transmitter assembly and maybe configured in any number of shapes and forms worn by the user, suchas a watch, necklace, lapel, phone, belt-mounted device, etc.

FIG. 3 illustrates a schematic representation of one variation ofhearing aid assembly 14 utilizing an extra-buccal transmitter assembly22, which may generally comprise microphone 30 for receiving sounds andwhich is electrically connected to processor 32 for processing theauditory signals. Processor 32 may be connected electrically totransmitter 34 for transmitting the processed signals to the electronicsand/or transducer assembly 16 disposed upon or adjacent to the user'steeth. The microphone 30 and processor 32 may be configured to detectand process auditory signals in any practicable range, but may beconfigured in one variation to detect auditory signals ranging from,e.g., 250 Hertz to 20,000 Hertz.

With respect to microphone 30, a variety of various microphone systemsmay be utilized. For instance, microphone 30 may be a digital, analog,and/or directional type microphone. Such various types of microphonesmay be interchangeably configured to be utilized with the assembly, ifso desired.

Power supply 36 may be connected to each of the components intransmitter assembly 22 to provide power thereto. The transmittersignals 24 may be in any wireless form utilizing, e.g., radio frequency,ultrasound, microwave, Blue Tooth® (BLUETOOTH SIG, INC., Bellevue,Wash.), etc. for transmission to assembly 16. Assembly 22 may alsooptionally include one or more input controls 28 that a user maymanipulate to adjust various acoustic parameters of the electronicsand/or transducer assembly 16, such as acoustic focusing, volumecontrol, filtration, muting, frequency optimization, sound adjustments,and tone adjustments, etc.

The signals transmitted 24 by transmitter 34 may be received byelectronics and/or transducer assembly 16 via receiver 38, which may beconnected to an internal processor for additional processing of thereceived signals. The received signals may be communicated to transducer40, which may vibrate correspondingly against a surface of the tooth toconduct the vibratory signals through the tooth and bone andsubsequently to the middle ear to facilitate hearing of the user.Transducer 40 may be configured as any number of different vibratorymechanisms. For instance, in one variation, transducer 40 may be anelectromagnetically actuated transducer. In other variations, transducer40 may be in the form of a piezoelectric crystal having a range ofvibratory frequencies, e.g., between 250 to 4000 Hz.

Power supply 42 may also be included with assembly 16 to provide powerto the receiver, transducer, and/or processor, if also included.Although power supply 42 may be a simple battery, replaceable orpermanent, other variations may include a power supply 42 which ischarged by inductance via an external charger. Additionally, powersupply 42 may alternatively be charged via direct coupling to analternating current (AC) or direct current (DC) source. Other variationsmay include a power supply 42 which is charged via a mechanicalmechanism, such as an internal pendulum or slidable electricalinductance charger as known in the art, which is actuated via, motionsof the jaw and/or movement for translating the mechanical motion intostored electrical energy for charging power supply 42.

In another variation of assembly 16, rather than utilizing anextra-buccal transmitter, hearing aid assembly 50 may be configured asan independent assembly contained entirely within the user's mouth, asshown in FIG. 4. Accordingly, assembly 50 may include an internalmicrophone 52 in communication with an on-board processor 54. Internalmicrophone 52 may comprise any number of different types of microphones,as described above. Processor 54 may be used to process any receivedauditory signals for filtering and/or amplifying the signals andtransmitting them to transducer 56, which is in vibratory contactagainst the tooth surface. Power supply 58, as described above, may alsobe included within assembly 50 for providing power to each of thecomponents of assembly 50 as necessary.

In order to transmit the vibrations corresponding to the receivedauditory signals efficiently and with minimal loss to the tooth orteeth, secure mechanical contact between the transducer and the tooth isideally maintained to ensure efficient vibratory communication.Accordingly, any number of mechanisms may be utilized to maintain thisvibratory communication.

In various embodiments, vibrations may be transmitted directly into theunderlying bone or tissue structures. As shown in FIG. 5A, an oralappliance 240 is illustrated positioned upon the user's tooth, in thisexample upon a molar located along the upper row of teeth. Theelectronics and/or transducer assembly 242 is shown as being locatedalong the buccal surface of the tooth. Rather than utilizing atransducer in contact with the tooth surface, a conduction transmissionmember 244, such as a rigid or solid metallic member, may be coupled tothe transducer in assembly 242 and extend from oral appliance 240 to apost or screw 246 which is implanted directly into the underlying bone248, such as the maxillary bone, as shown in the partial cross-sectionalview of FIG. 5B. As the distal end of transmission member 244 is coupleddirectly to post or screw 246, the vibrations generated by thetransducer may be transmitted through transmission member 244 anddirectly into post or screw 246, which in turn transmits the vibrationsdirectly into and through the bone 248 for transmission to the user'sinner ear.

FIGS. 5C and 5D illustrate additional dental implant embodiments. InFIG. 5C, the transducer assembly 242 contains the transmission member244, which in turn is connected to a snap fit housing 240. The snap fithousing 240 is securely snapped onto an implant 246 which has an exposedhead that receives the snap fit housing. The implant head can be animplant abutment that is threaded onto the implant fixture, or directlyconnected to the implant fixture as one piece. One piece implants avoidthe presence of microgaps, while multi-piece implants provide moreoptions for various clinical needs with fewer components. The implant246 is securely screwed into bone through the gingival 248. The cuttingend of the implant may contain cutting edges to facilitate directimplant placement without pre-drilling. The threads of the implant 246may have constant or progressive thread geometry along the length of thethreaded regions of the implant. Sharp edges can be used to promotecutting, and is more effectively utilized towards the apical end of theimplant. Rounded square threads are more effective in distributingforces and hence promote osseointegration. For rounded square threads,optimal stress distribution is obtained by controlling the width of eachthread (i.e. major diameter minus minor diameter) to be 40-50% of thethread pitch height; and by controlling the thread height (height of theregion that defines the major diameter) to be 50% of the thread pitch.Microgrooves may promote soft tissue adaptation to the implant and maybe placed in the implant above the threads, and therefore above thecrestal bone, in the region where the implant traverses the gingivaltissue. The transmucosal component may be constricted sightly to produceplatform switching-like effects. The surface texture (e.g. roughness)can dramatically alter biological bone response to the surface, as wellas the mechanical advantage due to increased surface area and increasedresistance to removal. Sand blasting, acid etching, plasma spraying,nucleation and growth, plasma etching, etc., are well known in the artto produce biocompatible surfaces. Tissue adaptation to the implant hasalso been shown to be improved with the addition of bioceramics, celladhesion molecules, and delivery of cytokines, drugs, genes, and growthfactors. The surface modification can include altering biological boneresponse to an implant surface using one of: texturing the implantsurface, physically modifying the implant surface, chemically modifyingthe implant surface, and biologically modifying the implant surface.Texturing is one way to perform physical modification. Other physicalmodification methods can include sandblasting, laser, grinding, milling,among others. Chemical modification of the implant surface can includevapor deposition, plasma etching, acid or base, or providing precursorsto growth biocompatible oxides, drugs, vitamin D, among others.Alternatively, biological modifications can be done, including providingcell adhesion molecules (fibronectin, laminin, etc.), extracellularmatrix molecules (collagen, figrinogen, etc.), cytokines, (peptides (RGDrepeats, etc.), growth factors (BMPs, FGFs, VEGF, etc.), for example.Turning now to FIG. 5D, a different way of inserting the implant in FIG.5C is shown. Whereas FIG. 5C shows a vertically placed implant, similarto the way natural teeth are aligned within the jaw bone, FIG. 5D showsa horizontally place implant. The implant in FIG. 5D may be apical tothe roots of the teeth, or placed in between the roots of the teeth.When placed apical to the roots, anatomical features is considered toensure adequate bone-to-implant contact. For example, the maxillarysinus apical to the maxillary posterior teeth may preclude that type ofplacement. On the buccal side, short vestibule area may also precludehorizontal placement above the roots of the teeth. In these and othercases, the implant can be placed horizontally, in between the roots ofthe adjacent teeth, where the maximum implant diameter must consider thewidth of the periodontal ligament space (0.25-0.3 mm) on each adjacentteeth. The bottom illustration in FIG. 5D shows in more detailsrelationship between the snap fit housing 240 and the implant 246. FIG.5D also shows the transmission member 244 positioned above the snap fithousing 240 and the head of the implant 246.

For a single implant or screw 246, the snap fit housing 240 is attachedto the transmission member 244. For multiple screw embodiments, only onescrew is needed for bone conduction, and the snap fit housing for theremaining screws can be attached to the respective screw heads withoutbeing connected to the transmission member 244.

FIG. 6 illustrates a partial cross-sectional view of an oral appliance250 placed upon the user's tooth TH with the electronics and/ortransducer assembly 252 located along the lingual surface of the tooth.Similarly, the vibrations may be transmitted through the conductiontransmission member 244 and directly into post or screw 246, which inthis example is implanted into the palatine bone PL. Other variationsmay utilize this arrangement located along the lower row of teeth fortransmission to a post or screw 246 drilled into the mandibular bone.

In yet another variation, rather utilizing a post or screw drilled intothe underlying bone itself, a transducer may be attached, coupled, orotherwise adhered directly to the gingival tissue surface adjacent tothe teeth. As shown in FIGS. 7A and 7B, an oral appliance 260 may havean electronics assembly 262 positioned along its side with an electricalwire 264 extending therefrom to a transducer assembly 266 attached tothe gingival tissue surface 268 next to the tooth TH. Transducerassembly 266 may be attached to the tissue surface 268 via an adhesive,structural support arm extending from oral appliance 260, a dental screwor post, or any other structural mechanism. In use, the transducer mayvibrate and transmit directly into the underlying gingival tissue, whichmay conduct the signals to the underlying bone.

For any of the variations described above, they may be utilized as asingle device or in combination with any other variation herein, aspracticable, to achieve the desired hearing level in the user. Moreover,more than one oral appliance device and electronics and/or transducerassemblies may be utilized at any one time. For example, FIG. 8illustrates one example where multiple transducer assemblies 270, 272,274, 276 may be placed on multiple dental implants. Although shown onthe lower row of teeth, multiple assemblies may alternatively bepositioned and located along the upper row of teeth or both rows aswell. Moreover, each of the assemblies may be configured to transmitvibrations within a uniform frequency range. Alternatively in othervariations, different assemblies may be configured to vibrate withinnon-overlapping frequency ranges between each assembly. As mentionedabove, each transducer 270, 272, 274, 276 can be programmed or presetfor a different frequency response such that each transducer may beoptimized for a different frequency response and/or transmission todeliver a relatively high-fidelity sound to the user.

Moreover, each of the different transducers 270, 272, 274, 276 can alsobe programmed to vibrate in a manner which indicates the directionalityof sound received by the microphone worn by the user. For example,different transducers positioned at different locations within theuser's mouth can vibrate in a specified manner by providing sound orvibrational queues to inform the user which direction a sound wasdetected relative to an orientation of the user. For instance, a firsttransducer located, e.g., on a user's left tooth, can be programmed tovibrate for sound detected originating from the user's left side.Similarly, a second transducer located, e.g., on a user's right tooth,can be programmed to vibrate for sound detected originating from theuser's right side. Other variations and queues may be utilized as theseexamples are intended to be illustrative of potential variations.

In variations where the one or more microphones are positioned inintra-buccal locations, the microphone may be integrated directly intothe electronics and/or transducer assembly, as described above. However,in additional variation, the microphone unit may be positioned at adistance from the transducer assemblies to minimize feedback. In oneexample, similar to a variation shown above, microphone unit 282 may beseparated from electronics and/or transducer assembly 280, as shown inFIG. 9. In such a variation, the microphone unit 282 positioned upon oradjacent to the gingival surface 268 may be electrically connected viawire(s) 264.

Although the variation illustrates the microphone unit 282 placedadjacent to the gingival tissue 268, unit 282 may be positioned uponanother dental implant, screw implant or another location within themouth. For instance, FIG. 10 illustrates another variation 290 whichutilizes an arch 19 connecting one or more dental implant retainingportions 21, 23, as described above. However, in this variation, themicrophone unit 294 may be integrated within or upon the arch 19separated from the transducer assembly 292. One or more wires 296 routedthrough arch 19 may electrically connect the microphone unit 294 to theassembly 292. Alternatively, rather than utilizing a wire 296,microphone unit 294 and assembly 292 may be wirelessly coupled to oneanother, as described above.

In yet another variation for separating the microphone from thetransducer assembly, FIG. 11 illustrates another variation where atleast one microphone 302 (or optionally any number of additionalmicrophones 304, 306) may be positioned within the mouth of the userwhile physically separated from the electronics and/or transducerassembly 300. In this manner, the one or optionally more microphones302, 304, 306 may be wirelessly coupled to the electronics and/ortransducer assembly 300 in a manner which attenuates or eliminatesfeedback, if present, from the transducer.

FIGS. 12A, 12B and 12C show various views of one embodiment of anelectro-magnetic based attachment to a dental implant for transmissionof vibrations to teeth. The dental implant includes an upper portion(implant head) and lower portion (threaded portion) with at least thelower portion assuming a generally tapered and conical shape. Whilevarious materials can be used to construct the implant, it is widelyrecognized that one of the more suitable materials for dental implantsis titanium. This is due, in part at least, to the fact that titanium isa very strong and light metal and is highly resistant to corrosion anddegradation even though when implanted the implant assumes a positionembedded within the alveolar bone structure of a patient.

In one embodiment, the implant can be provided with an anchoring pin orscrew that functions to securely anchor the implant within the alveolarbone of the patient. The anchoring pin prevents the implant fromrotating or becoming loose when the implant is embedded within thealveolar bone of the patient. The anchoring pin is of the self-tappingtype and includes a screw head 310, a smooth shank portion 321, and athreaded self-tapping portion 308. The anchoring pin is inserteddownwardly through an access opening and into the throughbore. Once inthe throughbore, the screw head 310 is engaged with a turning tool suchas a screw driver or Allen wrench that extends through the accessopening, and the anchoring pin is turned causing the self-tappingthreads 308 to be pulled within bone structure adjacent to the implant.The anchoring pin further anchors and secures the implant in place andis particularly designed to prevent the implant from rotating orbecoming loose under stress or load.

The implant can be utilized without an anchoring pin and can be insertedand stationed within the alveolar bone of a patient by simply screwingthe implant into the alveolar bone. In certain cases, the utilization ofan anchoring pin may assist in stabilizing and preventing the implantfrom rotating under load or stress.

FIG. 12A shows a top view of an implant having an implant head or ascrew head 310 and a vibratory transducer 312. The vibratory transducer312 can include a protective housing, or simply can include theelectronic components that are covered by a protective seal or coating.The screw head 310 is charged in a predetermined polarity (either northor south polarity). The vibratory transducer 312 is shaped to engage thescrew head 310 at opening 314. The vibratory transducer 312 contains amagnet 316 having the end facing the screw head 310 charged in anopposite polarity to the screw head's polarity. In this manner, thetransducer 312 and the screw head 310 are strongly attracted to eachother to secure the two together. Such tight physical coupling minimizesresonance vibrations that occur if the transducer 312 and the screw head310 were not attracted to each other.

FIG. 12B shows another means of attachment to the screw head. A screwhead 326 is secured to the bone portion 320 when a threaded portion 321is screwed into the bone portion 320. The screw head 326 supports a baseplate 332 through a pivot tab 328 that is secured to the screw head 326using a rod 330. A top plate 334 is positioned above the base plate 332and extends beyond the base plate 332 to engage a pair of arms 340-342positioned on the bottom of the vibratory transducer 312. Additionally,a ball 344 is positioned on the transducer 312 and is spring loaded (notshown) so that the transducer 312 and the ball 344 are adapted to locatea spherical indentation 346 on the top plate 334. During insertion ofthe transducer 312 into the screw head 310, the ball 344 engages thespherical indentation 346 to properly orient the transducer 312. Themagnet 316 encircles the ball spring 344 and opposing magnetic forcessecure the screw head 310 to the transducer 312 containing the magnet316. During insertion, the ball 344 drops into the spherical orientation346 to allow the transducer 312 to be properly positioned over the screwhead 310.

The vibratory transducer 312 may generally include a microphone forreceiving sounds and which is electrically connected to a processor forprocessing the auditory signals. The processor may be electricallyconnected to an antenna for receiving wireless communication signals,e.g., input control signals from an external remote control and/or otherexternal sound generating devices, e.g., cell phones, telephones,stereos, MP3 players, and other media players. The microphone andprocessor may be configured to detect and process auditory signals inany practicable range, but may be configured in one variation to detectauditory signals ranging from, e.g., 250 Hertz to 20,000 Hertz. Thedetected and processed signals may be amplified via amplifier, whichincreases the output levels for vibrational transmission by transducer312 into the adjacent, or otherwise coupled, bone structure 322 such asa patient's tooth or teeth.

With respect to microphone, a variety of various microphone systems maybe utilized. For instance, microphone may be a digital, analog,piezoelectric, and/or directional type microphone. Such various types ofmicrophones may be interchangeably configured to be utilized with theassembly, if so desired.

The signals transmitted may be received by electronics and/or transducerassembly via a receiver, which may be connected to an internal processorfor additional processing of the received signals. The received signalsmay be communicated to transducer 312, which may vibrate correspondinglyagainst a surface of the tooth to conduct the vibratory signals throughthe tooth and bone and subsequently to the middle ear to facilitatehearing of the user. Transducer 312 may be configured as any number ofdifferent vibratory mechanisms. For instance, in one variation,transducer 312 may be an electromagnetically actuated transducer. Inother variations, transducer 312 may be in the form of a piezoelectriccrystal having a range of vibratory frequencies, e.g., between 250 to20,000 Hz.

The implant process starts after a tooth extraction cavity has healedand closed. The first step is to determine the proper size implant froma standard kit or standard group of implants. Since the extractioncavity has now become closed and healed, the particular implant isselected based on the size and condition of the implant site. In anyevent, after the proper implant has been selected, the next step entailsdrilling a receiving cavity through the gum and alveolar bone of thepatient at the implant site. The particular drill is selected based onthe optimum size implant selected from the standard group of implants.But in any event, a drill guide is utilized and the selected drill bitis directed downwardly through the drill gauge into the alveolar bone ofthe patient creating an implant cavity. Once the bore has been createdthen the next step is to utilize a selected reamer, again based on theimplant selection. This also occurs after a tooth has been extracted andit is the intent of the dentist or oral surgeon to immediately set theimplant. In either case, a select reamer is chosen based on the optimumsize of the implant to be used. A reamer guide can be secured about theextraction cavity or the cavity formed by the drill. The reamer ispreferably of a conical or tapered shape and would generally conform tothe shape of the original root structure of the extracted tooth. Thecavity is reamed and the extraneous material resulting from the reamingis removed. Thereafter, as discussed herein before, the implant isinserted within the reamed cavity and anchored within the alveolar bone.Next; the anchoring pin or screw is extended through the throughbore andscrewed into the alveolar bone adjacent the implant. This couples theimplant to the alveolar bone and prevents rotation and loosening.

Complete osseointegration, i.e. the dynamic interaction of living bonewith a biocompatible implant without an intervening soft tissue layer,is preferred but not essential in all cases. When the bone quality issufficient (abundant bone volume and high bone density), immediateloading or delayed loading (weeks) may be considered since the forceparameters involved for this application are very low. There may be thepossibility that selected force parameters can promote the bone healing.

When the bone quality is insufficient (inadequate bone volume ordensity), then more healing time may be required for establishingimplant stability. In such cases, after the implant has been placed, theimplant site is closed in order that the same can heal for a period oftime. A temporary cap can be used, or the gingival flap may be returnedacross the top of the implant so as to close the same. However, it isalso possible to leave the implant head exposed during the healingperiod, similar to the ITI dental implant concept. Thereafter,osseointegration occurs, and bone structure remodels and heals inintimate contact with the implant without an intervening soft tissuelayer. The time for complete osseointegration can vary fromapproximately 3 to 12 months depending on the age of the patient andother factors. However, due to the force parameters of this application,the implant may be used without complete osseointegration. It is likelythat 1-3 months may be adequate for many cases. If a flap was placed andhealing was allowed to occur under the mucosal tissues, then after theappropriate healing time the dentist or oral surgeon can return to theimplant site and surgically opens the gingival flap and attach atransmucosal abutment for the vibratory transducer 312 to be mounted.

FIGS. 13A, 13B, 13C and 13D show various embodiments of mechanical basedattachments to implants for transmission of vibrations to teeth. Adental implant in FIG. 13A includes a threaded portion 308 that isapical to the gum line 320 and an implant head or screw head 326 thatextends above the bone region 320. A vibratory transducer 340 engagesthe screw head 326 to transmit or conduct sound through the bone region320. The vibratory transducer 340 has a plurality of springs 356 thatprovide spring-loaded forces to cause balls or tabs 358 to securelyengage the screw head 326. In one embodiment, the screw head 326 has aplurality of recesses 327 to engage the balls or tabs 358.

Referring now to FIG. 13B, another embodiment to mechanically attach thevibratory transducer 340 is shown. In this embodiment, the implant heador screw head 326 has an opening therethrough to receive one arm of aclip 352. The clip 352 has a supporting surface 334 that engages a topplate 346. In one embodiment, the top plate 346 has a ball 344 thatcooperates with a spherical indentation on the top place 334 to properlyposition the transducer 340 on the top plate 346. The implant head orscrew head 326 supports a base plate 364 through a pivot tab 360 that issecured to the screw head 326 using a second screw or rod 362. A topplate 368 is positioned above the base plate 364 and extends beyond thebase plate 364 to engage a pair of arms 378-380 positioned on the bottomof the vibratory transducer 376. Additionally, a ball 372 is positionedon the vibratory transducer 376 and is spring loaded through spring 374so that the vibratory transducer 376 and the ball 372 are adapted tolocate a spherical indentation 370 on the top plate 368. Duringinsertion or installation of the vibratory transducer 376 into the screwhead 326, the ball 372 engages the spherical indentation 370 to properlyorient the vibratory transducer 376.

In sum, the base plate 322 has a rod 352 or 330 attached to the baseplate 322. The rod 352 or 330 slides into the hole in the screw head 312or 326. The transducer portion then attaches to that base plate eitherwith a magnet as in FIG. 12B and FIG. 12C or mechanically as in FIG. 13Bor FIG. 13C. FIGS. 14A and 14B show two chemical embodiments forattaching the vibrational transducer to the screw head 312 or 326.

FIGS. 14A and 14B show various views of one embodiment of a chemicalbased attachment to implants for transmission of vibrations to teeth.FIG. 14A shows the vibratory transducer 382 prior to mounting on theimplant head or screw head 326, while FIG. 14B shows the completedtransducer and implant head or screw head assembly. An implant head orscrew implant in FIG. 32A includes a threaded portion 308 that is belowthe gum line 320 and a screw head 326 that extends above the bone region320. A vibratory transducer 382 engages the screw head 326 to transmitor conduct sound through the bone region 320. The vibratory transducer382 has a recess 383 that engages the screw head 326. To secure thetransducer 382 to the screw head 326, an adhesive layer 384 is providedat an interface between the transducer 382 and the screw head 326.

The implant can be used to treat tinnitus or stuttering. For stuttering,the implant can play frequency shifted and delayed version of the sounddirected at the patient and this delayed playback stops the patient'sstuttering. For example, the sound is frequency shifted by about 500 Hzand the auditory feedback can be delayed by about 60 ms. Theself-contained dental implant assists those who stutter. With the devicein place, stuttering is reduced and speech produced is judged to be morenatural than without the device.

The implant can treat tinnitus, which is a condition in which sound isperceived in one or both ears or in the head when no external sound ispresent. Such a condition may typically be treated by masking thetinnitus via a generated noise or sound. In one variation, the frequencyor frequencies of the tinnitus may be determined through an audiologyexamination to pinpoint the range(s) in which the tinnitus occurs in thepatient. This frequency or frequencies may then be programmed into aremovable oral device which is configured to generate sounds which areconducted via the user's tooth or bones to mask the tinnitus. One methodfor treating tinnitus may generally comprise masking the tinnitus whereat least one frequency of sound (e.g., any tone, music, or treatmentusing a wide-band or narrow-band noise) is generated via an actuatabletransducer positioned against at least one tooth such that the sound istransmitted via vibratory conductance to an inner ear of the patient,whereby the sound completely or at least partially masks the tinnitusperceived by the patient. In generating a wide-band noise, the soundlevel may be raised to be at or above the tinnitus level to mask notonly the perceived tinnitus but also other sounds. Alternatively, ingenerating a narrow-band noise, the sound level may be narrowed to thespecific frequency of the tinnitus such that only the perceived tinnitusis masked and other frequencies of sound may still be perceived by theuser. Another method may treat the patient by habituating the patient totheir tinnitus where the actuatable transducer may be vibrated within awide-band or narrow-band noise targeted to the tinnitus frequencyperceived by the patient overlayed upon a wide-frequency spectrum sound.This wide-frequency spectrum sound, e.g., music, may extend over a rangewhich allows the patient to periodically hear their tinnitus through thesound and thus defocus their attention to the tinnitus. In enhancing thetreatment for tinnitus, a technician, audiologist, physician, etc., mayfirst determine the one or more frequencies of tinnitus perceived by thepatient. Once the one or more frequencies have been determined, theaudiologist or physician may determine the type of treatment to beimplemented, e.g., masking or habituation. Then this information may beutilized to develop the appropriate treatment and to compile theelectronic treatment program file which may be transmitted, e.g.,wirelessly, to a processor coupled to the actuatable transducer suchthat the transducer is programmed to vibrate in accordance with thetreatment program.

In use, an implant containing the transducer may be placed against oneor more teeth of the patient and the transducer may be actuated by theuser when tinnitus is perceived to generate the one or more frequenciesagainst the tooth or teeth. The generated vibration may be transmittedvia vibratory conductance through the tooth or teeth and to the innerear of the patient such that each of the frequencies of the perceivedtinnitus is masked completely or at least partially. The oral implantmay be programmed with a tinnitus treatment algorithm which utilizes theone or more frequencies for treatment. This tinnitus treatment algorithmmay be uploaded to the oral appliance wirelessly by an externalprogramming device to enable the actuator to vibrate according to thealgorithm for treating the tinnitus. Moreover, the oral appliance may beused alone for treating tinnitus or in combination with one or morehearing aid devices for treating patients who suffer not only fromtinnitus but also from hearing loss.

The applications of the devices and methods discussed above are notlimited to the treatment of hearing loss but may include any number offurther treatment applications. Moreover, such devices and methods maybe applied to other treatment sites within the body. Modification of theabove-described assemblies and methods for carrying out the invention,combinations between different variations as practicable, and variationsof aspects of the invention that are obvious to those of skill in theart are intended to be within the scope of the claims.

1. An apparatus for transmitting vibrations via bone or tissue tofacilitate hearing in a patient, comprising: an implant having animplant head and a threaded portion adapted to be positioned below a gumline; and a housing coupled to the implant head and in vibratorycommunication with the implant head, the housing having an actuatabletransducer disposed within or upon the housing.